GERICARE Eyewash, sterile eye irrigating solution, packaged in a 4 fl oz (118 mL) bottle, OTC, Di...
FDA Recall #D-0551-2018 — Class I — November 9, 2017
Product Description
GERICARE Eyewash, sterile eye irrigating solution, packaged in a 4 fl oz (118 mL) bottle, OTC, Distributed by Geri-Care Pharmaceuticals Corp., Brooklyn, NY 11204, NDC 57896-0186-04
Reason for Recall
Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans
Recalling Firm
Kareway Products Inc — Compton, CA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
60,000 bottles
Distribution
Product was shipped to one customer (Geri-Care Pharmaceuticals Corp.) who further distributed the product U.S.A. nationwide.
Code Information
Lot #: 86041601, Exp 09/19
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated